Medtronic Receives FDA Clearance For Two Heart Devices

The federal approvals came from Monday and Tuesday of this week.

Medtronic received FDA approval for two of its heart devices this week, one of which was a first-of-its-kind approval given to an existing product by the medical device maker.

The company’s Melody transcatheter pulmonary valve (TPV) was given the green light to be sold to doctors on Tuesday as an implantation for those whose surgical bioprosthetic pulmonary heart valves have failed.

For years, doctors have used bioprosthetic implants to treat patients with a congenital heart defect in their right ventricular outflow tract conduit. Patients that receive the bioprosthetic device must undergo open-heart surgery, although the device is known to degenerate over time, which commonly leads to additional open-heart surgeries to replace the device.

In contrast, the Melody TPV is a minimally invasive treatment option comprised of a bovine jugular vein and metal frame. Aside from being considerably easier to insert than its bioprosthetic counterpart, several studies have proven that the device can prolong the time between the need for open-heart surgeries.

“As the first commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits,” Jeremy Asnes, director of the Congenital Cardiac Catheterization Laboratory at the Yale School of Medicine, said in a statement. “With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.”

Additionally, on Monday, the company received FDA clearance to sell a new and improved version of its Reveal Linq Insertable Cardiac Monitor (ICM). The device was also cleared for use with a monitoring system called TruRhythm Detection, which is said to help reduce episodes of false bradycardia (slow heartbeat) and false pause (brief absence of cardiac activity).

“ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” said James Allred, an electrophysiologist at North Carolina-based Cone Health Medical Group Heartcare.

Previous versions of the Linq device have been big money makers for Medtronic, drawing in more than $500 million in annual revenue, the Star Tribune reported.

The Linq device, which is about one-third the size of a AAA battery, is used to monitor a patient’s heart after they have experienced unexplained fainting. A significant draw to Linq device is its battery life, which is said to last 3 years versus the 30-day average of competing devices.

“The enhancements with the Reveal Linq ICM with TruRhythm Detection,” Allred added, “make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”

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